Regulatory Affairs

Our Regulatory Affairs experts provide one of the core services at Clinical Accelerator.  We provide a regulatory service for all locations in which we operate. A dedicated team offers a personal approach to provide a comprehensive range of submission and approval-related services for our clients. Our Regulatory Affairs expertise and knowledge of a potentially complex regulatory environment will make all the difference when submitting your clinical trial for approval.  We can handle:

  • Competent Authority submissions
  • Ethics Opinions and Approvals
  • Contracting
  • Other relevant permissions

Regulatory processes in the non-EU countries in which we operate (Russia, Ukraine,  Moldova, Georgia) are different from countries covered by EU Directives and Regulations. Handling it competently requires full knowledge of the local legislation and monitoring of frequent updates issued by the relevant authorities. We are experts in all regulatory affairs and handle everything correctly – this results in very few rate-limiting issues and a process which is generally much swifter and less burdensome than that in the EU countries or the US.

You can also rely on our professional team to take care of all ongoing communication with the relevant regulatory agency.  You can be sure that Clinical Accelerator will handle all details of the clinical research compliance process in a timely manner, including:

  • Amendments
  • Serious Adverse Event (SAE) reporting
  • SUSARs
  • Annual reports
  • Study close-out reports